Transvenous Implantable Cardioverter‐Defibrillator Lead Reliability: Implications for Postmarket Surveillance
Why the study?
Does the choice of transvenous implantable cardioverter-defibrillator lead manufacturer affect lead failure rates in patients receiving ICDs?
Population
2,653 patients who received transvenous implantable cardioverter-defibrillator leads between January 1, 2006…
Comparison
Transvenous implantable cardioverter-defibrillato… vs Comparison among different lead manufacturers
Design
Cohort
Follow-up
median 3.2 years
Authors
Discussion
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Member takes
Implication
May indicate higher Durata failure risk; leaves open need for prospective studies on contemporary transvenous ICD lead reliability.
Structured PICO
Does the choice of transvenous implantable cardioverter-defibrillator lead manufacturer affect lead failure rates in patients receiving ICDs?
P
Population
2,653 patients (median age 65, 73% male) who received transvenous implantable cardioverter-defibrillator leads between January 1, 2006 and September 1, 2012
I
Intervention
Transvenous implantable cardioverter-defibrillator leads (Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim)
C
Comparator
Comparison among different lead manufacturers (Medtronic vs. Boston Scientific vs. St Jude Medical)
O
Outcome
Lead failure ratesafety
Currently marketed transvenous ICD leads have a very low failure rate of 0.28% per year, with no significant differences among major manufacturers, suggesting that very large sample sizes are needed for comparative effectiveness studies.
Cite This Study
Kramer et al. (2015) studied this question.